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Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age
This study has been completed.
First Received: March 5, 2009   No Changes Posted
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00858468
  Purpose

Primary Objectives:

  • To describe the percentage of protective HAI antibody titers (following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among the investigational and control groups.
  • To describe the safety of the 2004-2005 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the package insert for vaccine-naïve young children) to the investigational and control groups.

Condition Intervention Phase
Influenza
Biological: Influenza virus vaccine (2004-2005 Formulation)
Phase I
Phase II

MedlinePlus related topics: Flu
Drug Information available for: Fluvirin Influenza Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of Fluzone among the investigational and control groups. [ Time Frame: Day 56 (21 to 35 days post-vaccination 2) ] [ Designated as safety issue: No ]
  • To provide information concerning the safety of Fluzone vaccination. [ Time Frame: 7days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 394
Study Start Date: April 2005
Study Completion Date: December 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Age 6 to 12 Weeks: Experimental
Participants aged 6 to 12 Weeks at enrollment
Biological: Influenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
Age 24 to 36 Weeks: Experimental
Participants aged 24 to 36 Weeks at enrollment
Biological: Influenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular

Detailed Description:

This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to 12 weeks (the investigational group, also referred to as the 2-month-old group) versus children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group). The study is not designed to achieve any preset statistical power, and no hypotheses will be tested.

  Eligibility

Ages Eligible for Study:   2 Months to 9 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
  • Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
  • Considered to be in good health on the basis of reported medical history and history-directed physical examination.
  • Available for the duration of the study.
  • Parent/guardian willing and able to provide informed consent.
  • Parent/guardian able to attend all scheduled visits and comply with all trial procedures.
  • Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.

Exclusion Criteria :

  • Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
  • Previous history of influenza vaccination or documented history of influenza infection.
  • Receipt of any vaccine in the 7 days prior to enrollment.
  • An acute illness with fever (rectal temperature ≥ 38.0°C [or ≥ 100.4°F]) in the 72 hours preceding enrollment in the trial (defer enrollment).
  • Known bleeding disorder.
  • Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this study.
  • Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Personal or immediate family history of congenital immune deficiency.
  • Developmental delay, neurologic disorder, or seizure disorder.
  • Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion.
  • Known HIV-positive or HBsAg-positive mother.
  • Known HIV, hepatitis B (HBsAg), or hepatitis C infection.
  • Blood or blood-derived products received in the past 2 months.
  • Prior history of Guillain-Barré syndrome.
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858468

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, Georgia
Marietta, Georgia, United States, 30062
United States, North Carolina
Durham, North Carolina, United States, 27705
United States, Ohio
Akron, Ohio, United States, 44308
Dayton, Ohio, United States, 45404
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
United States, Washington
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: GRC27
Study First Received: March 5, 2009
Last Updated: March 5, 2009
ClinicalTrials.gov Identifier: NCT00858468     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Influenza
Influenza vaccine

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:
Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 06, 2009